Group 1 - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which is required to clarify the progress of state-owned shareholder compliance with state asset management procedures [1] - The CSRC requests Shimai Pharmaceutical to provide legal opinions on several matters, including the pricing basis for past capital increases and share transfers, and whether there are any irregularities in the pricing [1] - The company must also clarify whether its business operations involve restricted foreign investment areas, particularly in relation to human stem cells and gene diagnosis and treatment technologies [1] Group 2 - The company, established in 2017, is a pioneer in next-generation T-cell engagers (TCE) therapy and a global leader in this field [2] - TCEs are designed to simultaneously bind to tumor-associated antigens on cancer cells and receptors on T-cells, directing them to tumor tissues to activate T-cells for targeted cytotoxic effects [2] - The company has developed innovative clinical-stage products, including a next-generation TCE that can be selectively activated in tumors for the treatment of solid tumors [2]

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor [1]. Company Overview - Established in 2017, the company is a pioneer and global leader in next-generation T-cell engagers (TCE) therapy, designed to direct T-cells to tumor tissues and activate them to induce targeted cytotoxic effects [3][4]. - The company has developed a next-generation TCE therapy that selectively activates in tumors for the treatment of solid tumors, with a significant market potential [3][4]. Product Pipeline - As of November 5, 2025, the company has four clinical-stage candidates: 1. DNV3, targeting LAG3 2. SMET12, an intravenous EGFR×CD3 TCE 3. CMD011, a GPC3×CD3 TCE 4. CMDE005, a next-generation EGFR×CD3 TCE [4]. - Additionally, two preclinical candidates are in development, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3 [4]. Financial Performance - The company reported revenues of RMB 14.649 million, RMB 6.618 million, and RMB 2.278 million for the years 2023, 2024, and the first half of 2025, respectively [7][9]. - Losses for the same periods were RMB 74.943 million, RMB 59.899 million, and RMB 25.420 million [7][9]. - Research and development expenses were RMB 76.109 million, RMB 53.382 million, and RMB 22.389 million for the years 2023, 2024, and the first half of 2025, respectively [8][9]. Market Overview - The global TCE market is projected to grow from USD 4 billion in 2020 to USD 30 billion in 2024, with a compound annual growth rate (CAGR) of 67.6% [12]. - By 2035, the global TCE market is expected to reach USD 121.1 billion [12]. - The Chinese TCE market is anticipated to grow from RMB 1 billion in 2021 to RMB 7 billion in 2024, with a CAGR of 104.0% [12]. By 2035, it is expected to reach RMB 159.6 billion [12]. Board of Directors - The board consists of 9 members, including 3 executive directors, 3 non-executive directors, and 3 independent non-executive directors [15].